New Versus Existing Auto-titrating CPAP Device to Treat Obstructive Sleep Apnea in Adults

NCT01210261 | Completed DMC

• 2 other identifiers: SPAP00110244A
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive sleep apnea (OSA) is a condition of disordered breathing characterised by intermittent partial and/or complete upper airway obstruction during sleep. The participants, naive to nasal continuous positive airway pressure (CPAP), recently diagnosed with OSA, will undergo two automatic CPAP titration studies with collection of polysomnographic (PSG) data. The data will be analysed to assess effectiveness of Compumedics auto-CPAP device in the normalisation of sleep disordered breathing in OSA patients, with respect to another auto-CPAP device.

Conditions

Sleep Apnea, Obstructive

Keywords

OSA; CPAP; APAP; SPAP; Obstructive Sleep Apnea; Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Apnea Hypopnea Index (AHI) difference between test and reference APAP treatment

  AHI is the number of apnea and hypopnea events per hour of sleep

  Up to 8 weeks after study completion

Secondary Outcomes (7)

• AHI difference between test treatment and baseline

  Up to 8 weeks after study completion

• Arousal Index (AI) differences between the test and reference APAP treatments and between the test treatment and baseline

  Up to 8 weeks after study completion

• Respiratory Disturbance Index (RDI) differences between the test and reference APAP treatments and between the test treatment and baseline

  Up to 8 weeks after study completion

• Sleep Efficiency (SE) differences between the test and reference APAP treatments and between the test treatment and baseline

  Up to 8 weeks after study completion

• Oxygen desaturation index (DI) differences between the test and reference APAP treatments and between the test treatment and baseline

  Up to 8 weeks after study completion

Study Arms (2)

Autoset S8

ACTIVE COMPARATOR

Single night auto-titrating CPAP treatment using the reference device (Resmed Autoset S8) with polysomnographic monitoring

Device: Resmed Autoset S8 - Auto-titrating CPAP

Somnilink SPAP

EXPERIMENTAL

Single night auto-titrating CPAP treatment using the test device with polysomnographic monitoring

Device: Compumedics Somnilink SPAP - Auto-titrating CPAP

Interventions

Compumedics Somnilink SPAP - Auto-titrating CPAP DEVICE

Subjects will undergo the auto-titrating CPAP treatments in the Monash Sleep Centre with the test and reference devices during two nights in random order. There will be an interval of at least seven days between the two treatments to eliminate the carryover effect. Full polysomnographic (PSG) recording will be conducted during both treatment nights. The recorded physiological signals during PSG will include signals identical to those used during the baseline diagnostic PSG. The patients fill KSS questionnaire immediately after the PSG study. All PSG recordings (both treatment studies and the baseline diagnostic study) will be scored according to the AASM rules by the same sleep technician blinded to the presence and type of auto-titrating CPAP treatment.

Also known as: Somnilink SPAP

Somnilink SPAP

Resmed Autoset S8 - Auto-titrating CPAP DEVICE

Subjects will undergo the auto-titrating CPAP treatments in the Monash Sleep Centre with the test and reference devices during two nights in random order. There will be an interval of at least seven days between the two treatments to eliminate the carry-over effect. Full polysomnographic (PSG) recording will be conducted during both treatment nights. The recorded physiological signals during PSG will include signals identical to those used during the baseline diagnostic PSG. The patients fill KSS questionnaire immediately after the PSG study. All PSG recordings (both treatment studies and the baseline diagnostic study) will be scored according to the AASM rules by the same sleep technician blinded to the presence and type of auto-titrating CPAP treatment.

Also known as: Autoset S8

Autoset S8

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 18.
• Ability to give informed consent.
• OSA diagnosis and referral for clinical CPAP implementation at the Monash Sleep Centre within 3 months of recruitment.

You may not qualify if:

• Inability to give informed consent.
• Significant central sleep apnea (AHI for central events \>= 5).
• Congestive heart failure.
• Co-existing obesity related hypoventilation.
• Nasal obstruction, mouth breathing or other anatomical or physiological conditions making CPAP therapy inappropriate.
• History of prior CPAP treatment.
• Previous reaction to skin preparation, tapes and electrode gels used at PSG.

Sponsors & Collaborators

• Compumedics Limited: lead

Study Sites (1)

Department of Respiratory & Sleep Medicine, Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Garun Hamilton, PhD

  Director of Sleep Research, Department of Respiratory & Sleep Medicine, Monash Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2010
• First Posted: September 28, 2010
• Study Start: May 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: April 5, 2012

Record last verified: 2012-04

Locations

AU (1)